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A pilot study of add on Acetazolamide to anti-psychotic treatment in patients with schizophrenia

A pilot open label study of Acetazolamide as an adjuvant to anti-psychotic treatment in patients with schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016340
Enrollment
30
Registered
2018-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: ACETAZOLAMIDE PLUS THIAMINE: [ORAL ACETAZOLAMIDE UPTO 2 GRAMS PLUS ORAL THIAMINE UPTO 1500 MG ] WITH TREATMENT AS USUAL IN PERSONS WITH STABLE SCHIZOPHRENIA FOR A PERIOD OF 8 WEEKS ONL

Sponsors

UNIVERSITY OF PITTSBURGH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed as schizophrenia by DSM 5 criteria using Structured Clinical Interview for DSM disorders (SCID), aged between 18-50 years. Patients who have residual positive symptoms and are clinically stable. Residual positive symptoms criteria: Participants will be required to meet the following symptom criteria: 1) PANSS total score of 60 or more, and 2) a PANSS score of 4 or more on at least one positive symptom. Stability Criteria and concomitant Antipsychotic drug use (APD): Participants will be clinically stable and treated with the same APD for at least 60 days with a constant therapeutic dose for at least 30 days prior to the study. There will not be any restrictions on the type of APD with which the participant is treated, except patients administered clozapine for less than one year prior to study admission, since they require frequent blood tests. Without any co-morbid psychiatric illness other than nicotine and caffeine use

Exclusion criteria

Exclusion criteria: Persons currently on Acetazolamide or Thiamine for any medical reasons. Suicidal ideation currently Already diagnosed medical conditions in which acetazolamide is contraindicated like hyperchloremic acidosis, hypokalemia, hyponatremia, adrenal insufficiency, impaired kidney function, hypersensitivity to acetazolamide or other sulphonamides, liver diseases as per baseline clinical examination and relevant biochemical tests. Persons taking any other diuretics and Aspirin. Pregnant and lactating women (Pregnancy test will be done prior to the recruitment) Persons diagnosed with intellectual disability Known hypersensitivity to sulphonamide derivatives

Design outcomes

Primary

MeasureTime frame
Is ACETAZOLAMIDE +THIAMINE augmentation tolerated by Indian patients with schizophrenia who have partial response to antipsychotic medications?Timepoint: 8 WEEKS

Secondary

MeasureTime frame
Assay of erythrocyte carbonic anhydrase activity in patients with Schizophrenia treated with Acetazolamide plus Thiamine or Thiamine.Timepoint: 8 WEEKS;Estimate effect size for change in antipsychotic induced weight gain in schizophrenia due to Acetazolamide plus Thiamine versus ThiamineTimepoint: 8 weeks;Estimate effect size for change in positive and negative symptoms due to Acetazolamide plus Thiamine versus Thiamine.Timepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Anil Kakunje

YENEPOYA UNIVERSITY

anilpsychiatry@yahoo.co.in9845312940

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026